Intuitive Surgical Recalls da Vinci Single Site Instruments for Missing Manual Revisions
Intuitive Surgical is recalling da Vinci Single Site Bipolar Maryland Forceps and curved needle drivers shipped with incorrect user manuals.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is a missing manual revision with no reported illnesses or injuries, fitting the criteria for a moderate severity documentation/labeling issue.
Plain-English summary
Intuitive Surgical, Inc. is recalling a limited number of FDA-cleared da Vinci Single Site instruments, specifically the Bipolar Maryland Forceps and curved needle drivers. The recall is due to these instruments being shipped without the correct revision of the user manual. The missing manual revision contained added instructions for use, including indications, warnings, and precautions for these specific Single Site instruments.
The affected products are Model number 428080-04. The distribution period for the affected units was from March 15, 2013, to July 19, 2013. A total of 286 boxes, containing 6 instruments per box for a total of 2,220 affected clinical products, were distributed. The distribution was worldwide, including the United States (nationwide), Australia, Belgium, France, Italy, and the United Kingdom.
This recall involves a documentation error where the provided user manual did not match the specific instrument revision. No illnesses or injuries have been reported in the source text. Users should verify their instrument model and lot numbers against the recall list and contact Intuitive Surgical for the correct manual revision.
The recalled product
- Product
- Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room…
- Manufacturer
- Intuitive Surgical, Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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